First Bites: Complementary Feeding - A Global Network Cluster Randomized Controlled Trial (First Bites)

November 22, 2013 updated by: NICHD Global Network for Women's and Children's Health

Complementary Feeding - A Global Network Cluster Randomized Controlled Trial

The specific aims of this project is to determine the impact of a daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo) on linear growth velocity, zinc and iron intakes and status, brain growth and neurocognitive development, and infectious disease morbidity in populations traditionally dependent on non-micronutrient fortified plant foods for complementary feeding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children. Prominent among nutrient inadequacies are those of iron and zinc. While huge campaigns are being mounted to fortify complementary foods and to distribute supplements, the effectiveness of these programs is generally uncertain and they do not reach millions of rural poor. By comparison, little support is being given to local food-based solutions. These not only require diversity of plant foods but appear to require the inclusion of meat to achieve zinc and iron requirements. Local supplies of meat are achievable but only with a concerted international and local effort. To justify this effort requires a multi-site efficacy study, the results of which, if positive, will leave no doubt that the effort required to provide sustainable local sources of meat for complementary feeds is worthwhile. The principal hypothesis to be tested is that daily intake of beef (1 oz/d for 6-12 mo and 1.5 oz/d for 12-18 mo) added to usual primarily plant-derived complementary feeds plus selected repetitive nutrition education messages results in greater linear growth velocity than does a micronutrient (including Zn and Fe) fortified equi-caloric cereal/legume supplement plus the same educational messages. Participants from four sites in the Global Network which have stunting rates > 20%, i.e. Guatemala, Pakistan and Zambia will be randomized by clusters to receive either ½ oz lyophilized beef (equivalent to 1 oz cooked beef)/d or the equi-caloric micronutrient-fortified plant-based supplement (both increasing by 50% at age 1 year). Both groups will receive three repetitive messages delivered by study coordinators and through the local health system as part of integrated health care. These are: provide a thick puree/gruel; feed complementary foods at least three times per day; and maximize dietary diversity. These interventions will be preceded by messages to promote exclusive breast feeding until 6 months and to start complementary feeding promptly at that time as far as possible. The meat or fortified cereal supplement will be provided daily in a group setting for each cluster; as necessary the food intervention and messages will be delivered at home by the assigned community coordinator or alternate. Outcome measures, obtained by a separate group of local, trained assessment workers, include: longitudinal linear growth between 6-18 months (primary outcome); weight and head circumference; assessment of dietary variety and diversity at 6,9,12, and 18 months; indices of iron, zinc and Vitamin B12 status at 18 months; neurocognitive development at 18 months; and incidence of diarrhea and lower respiratory infections. A positive multi-country, multi-culture outcome of this trial will demonstrate the efficacy of a regular intake of meat commencing at age 6 months to achieve nutritionally complete complementary feeding and will provide a strong rationale for global efforts to enhance local supplies of meat and achieve acceptance of meats as complementary food.

Study Type

Interventional

Enrollment (Actual)

1236

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Congo
      • Karawa, Congo
        • Kinshasa School of Public Health
  • Guatemala
      • Chiimaltenango, Guatemala
        • Institute for Nutrition of Central America and Panama (INCAP)
  • Pakistan
      • Karachi, Pakistan
        • Agha Khan University
  • Zambia
      • Lusaka, Zambia
        • University of Zambia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 4 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion criteria for clusters: Each cluster will be a rural community characterized by inhabitants with low income and served by one community health center. A primary criterion is that national or other available statistics indicate a prevalence of stunting (mean length for age Z-scores in second year < -2) of at least 20% in young children.

  • Inclusion criteria for individual families:

    • Infant aged 3-4 months;
    • Primarily or exclusively breast feeding with intent to continue breast feeding through at least 1 year.

Exclusion Criteria:

  • Exclusion criteria for individual families: Exclusion criteria include any population/family that is receiving or likely to receive free or subsidized complementary foods (or infant formula) through the health system or NGOs; any individual families who are feeding or intend to feed fortified infant formula or micronutrient-fortified commercial complementary foods.

  • Exclusion criteria for infants: Infants meeting the following criteria will be excluded from participation:

    1. known congenital anomaly;
    2. infant of multiple births;
    3. known neurological deficit apparent at the time of enrollment (including seizures).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo)
Other: Lyophilized meat
Daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo)
Active Comparator: 2
Daily intake of an equi-caloric fortified cereal as complementary feed from 6 to 18 months.
Other: Cereal
Daily intake of an equi-caloric fortified cereal as complementary feed from 6 to 18 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Linear growth velocity
Time Frame: 6 to 18 months of age
6 to 18 months of age

Secondary Outcome Measures

Outcome Measure
Time Frame
Infant Zinc and Ferritin levels
Time Frame: 18 months
18 months
Bayleys II
Time Frame: 18 months
18 months
Incidence of diarrhea, lower respiratory infection, and malaria
Time Frame: 6 to 18 months
6 to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NICHD Global Network for Women's and Children's Health

Collaborators

University of Colorado, Denver
University of Alabama at Birmingham
University of North Carolina, Chapel Hill
Aga Khan University
RTI International
Drexel University
University of Zambia
Kinshasa School of Public Health
INCAP, Chiimaltenango, Guatemala

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

March 9, 2010

First Submitted That Met QC Criteria

March 9, 2010

First Posted (Estimate)

March 10, 2010

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 22, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GN CF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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